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February 10, 2012

clopidogrel bisulfate, Plavix (cont.)

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PREGNANCY: There are no adequate studies of clopidogrel in pregnant women. Therefore, it can be used in pregnancy if the physician determines that it is needed.

NURSING MOTHERS: Studies in rats have shown that clopidogrel appears in breast milk; however, it is not known whether it also appears in human breast milk. Because of a potential for side effects in the nursing infant, the physician must weigh the potential benefits and possible risks before prescribing clopidogrel in nursing mothers.

SIDE EFFECTS: The tolerability of clopidogrel is similar to that of aspirin. Diarrhea, rash, or itching occurs in approximately 1 in 20 persons taking clopidogrel. Abdominal pain also occurs in about 1 in 20 persons, but it is less frequent than with aspirin.

Ticlopidine (Ticlid) is an antiplatelet medication quite similar to clopidogrel. It has been associated with a severe reduction in white blood cell count in between 0.8% and 1% of persons. The risk of this dangerous side effect with clopidogrel is about 0.04%, much less than with ticlopidine but twice that of aspirin.

Clopidogrel rarely causes a condition called thrombotic thrombocytopenic purpura (TTP) in one out of every 250,000 people. TTP is a serious condition in which blood clots form throughout the body. Blood platelets, which participate in clotting, are consumed, and the result can be bleeding because enough platelets are no longer left to allow blood to clot normally. For comparison, the related drug, ticlodipine (Ticlid), causes TTP 17-50 times more frequently than clopidogrel.

Reference: FDA Prescribing Information


Last Editorial Review: 1/4/2011



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